[A comparison of efficacy and tolerance of nateglinide and acarbose monotherapy in type 2 diabetes mellitus].

OBJECTIVE: To compare the efficacy and tolerability of nateglinide with those of acarbose in Chinese type 2 diabetes mellitus (T2DM) patients. METHODS: This multi-center, randomized, double-blind, parallel-arm study compared the efficacy and tolerability of nateglinide (120 mg, 3/d, n = 119) and those of acarbose (100 mg, 3/d, n = 118) during a 12-week treatment in T2DM patients uncontrolled by diet with glycosylated haemoglobin (HbA1c) 6.5% - 11.0%. RESULTS: Monotherapy with nateglinide (120 mg, 3/d) or acarbose (100 mg, 3/d) decreased HbA1c to a similar extent during 12-week treatment. The mean change from baseline to end-point in HbA1c was (-0.90 +/- 0.98)% and (-0.83 +/- 0.81)% in patients receiving nateglinide and acarbose, respectively, with no significant difference between the two groups (P > 0.05). The decrease in fasting plasma glucose (FPG) was similar between nateglinide and acarbose (P > 0.05). The mean change in 2-hour postprandial plasma glucose (PG2h) was (-1.45 +/- 2.74) mmol/L and (-2.20 +/- 2.21) mmol/L in patients receiving nateglinide and acarbose (P = 0.0017). Body weight was significantly decreased in both groups at the end-point (P < 0.05), although the decrease was more with acarbose than nateglinide [(-0.66 +/- 1.79) kg vs (-2.06 +/- 2.00) kg, P = 0.0000]. And the proportion of patients experiencing any presumed drug related adverse events was not significantly different between the two groups. CONCLUSIONS: Nateglinide (120 mg, 3/d) is effective and well tolerated in T2DM patients uncontrolled by diet, demonstrating similar HbA1c reductions as compared with acarbose (100 mg, 3/d).

[The safety and efficacy of rosiglitazone maleate in the treatment of patients with type 2 diabetes mellitus in China].

OBJECTIVE: To assess the clinical safety and efficacy of rosiglitazone maleate in the treatment of patients with type 2 diabetes mellitus. METHODS: A multi-center, open-label and 12-week duration study comprising of three cohorts, rosiglitazone maleate mono-therapy, rosiglitazone maleate plus metformin (Met) or sulphonylurea (SU) was carried out. RESULTS: A total of 2 308 patients enrolled in the study; but 2 134 completed and 174 withdrew from it. The percentages of patients reporting on-therapy adverse events were similar in the three cohorts. The most frequent adverse experiences were hyperlipidaemia (9.77%), upper respiratory tract infection (6.11%) and oedema (5.32%). There were totally 11 patients with serious, on-therapy adverse experiences. All serious adverse events (SAE) were considered by the investigator being not related to study medication except one case of SAE which was considered to be possibly related to the study medication. The mean levels of ALT in the three treatment cohorts were all reduced from baseline (25.5 IU/L) after treatment of 12 weeks (22.8 IU/L). Minor decreases in haemoglobin and haematocrit were observed in all treatment cohorts. Slight increases in total cholesterol, low density lipoprotein cholesterol and triglyceride were observed following 12 weeks of treatment, whereas high density lipoprotein cholesterol remained stable. In the efficacy evaluable population, the fasting plasma glucose reduction following 12 weeks of treatment was 1.70 mmol/L in the rosiglitazone maleate mono-therapy cohort, 1.47 mmol/L in the rosiglitazone maleate plus SU cohort and 1.36 mmol/L in the rosiglitazone maleate plus Met cohort, respectively. CONCLUSIONS: In this 12-week phase IV study, rosiglitazone maleate was found to be safe and well tolerated in all the three cohorts receiving rosiglitazone maleate as monotherapy or in combination with SU or MET for a large sample of population of patients with type 2 diabetes. Statistically significant reduction in fasting plasma glucose was observed in all the treated cohorts.

[An epidemiological study on diabetic retinopathy among type 2 diabetic patients in Shanghai].

OBJECTIVE: To investigate the prevalence and risk factors of diabetic retinopathy (DR) among type 2 diabetic patients aged over 30 in Shanghai central area. METHODS: 1039 patients diagnosed with type 2 diabetes mellitus (DM) aged over 30 were investigated by randomized cluster sampling in Shanghai central area and data from 767 of those patients were analyzed. RESULTS: (1) Among all of the 1534 digital ocular fundus images from 767 patients, 87.6% of the images from 672 patients were gradable. (2) Among all of the 672 patients with gradable ocular fundus images, the prevalence of non-proliferative diabetic retinopathy (NPDR) was 21.6%, while proliferative diabetic retinopathy (PDR) was 1.3%. The rates of mild, moderate and severe NPDR were 8.8%, 11.2% and 1.6% respectively. (3) DR patients were characterized with elder age, higher HbA1c, urea nitrogen and serum creatinine. DM duration and the level of fasting plasma glucose were risk factors for DR. CONCLUSION: The overall prevalence of DR in type 2 diabetic patients aged over 30 in Shanghai central area was 22.9% and the DR risk factors were found to include duration of diabetes and fasting plasma glucose level.